OTCQB-CSDX Appoints Lachman Consultants for CS-Protect Hydrogel FDA Approval
CS Diagnostics Corp. (OTCQB:CSDX) has appointed Lachman Consultants to support FDA approval for its CS-Protect Hydrogel, an innovative organ spacer medical device for cancer radiology treatments. The company expects FDA approval within 3-4 months.
CS-Protect Hydrogel is a ready-to-use product that offers enhanced versatility compared to previous products, featuring advanced molecular structure and chemical physical properties. The product requires no preparation steps after removal from sterile packaging, eliminating contamination risks.
The company projects production start in the U.S. market by Q1 2026. Management notes that a predecessor product in this space was acquired by Boston Scientific for $500 million, highlighting the potential market value of such technology.
CS Diagnostics Corp. (OTCQB:CSDX) ha nominato Lachman Consultants per supportare l'approvazione della FDA per il suo CS-Protect Hydrogel, un innovativo dispositivo medico di separazione per trattamenti radiologici contro il cancro. L'azienda si aspetta l'approvazione della FDA entro 3-4 mesi.
CS-Protect Hydrogel è un prodotto pronto all'uso che offre una versatilità superiore rispetto ai prodotti precedenti, con una struttura molecolare avanzata e proprietà chimico-fisiche innovative. Il prodotto non richiede passaggi di preparazione dopo essere stato rimosso dall'imballaggio sterile, eliminando i rischi di contaminazione.
L'azienda prevede di avviare la produzione nel mercato statunitense entro il primo trimestre del 2026. La direzione sottolinea che un prodotto predecessore in questo settore è stato acquisito da Boston Scientific per 500 milioni di dollari, evidenziando il potenziale valore di mercato di tale tecnologia.
CS Diagnostics Corp. (OTCQB:CSDX) ha nombrado a Lachman Consultants para apoyar la aprobación de la FDA de su CS-Protect Hydrogel, un innovador dispositivo médico separador para tratamientos de radiología oncológica. La empresa espera la aprobación de la FDA en un plazo de 3-4 meses.
CS-Protect Hydrogel es un producto listo para usar que ofrece una versatilidad mejorada en comparación con productos anteriores, con una estructura molecular avanzada y propiedades físico-químicas. El producto no requiere pasos de preparación después de ser retirado del empaque estéril, eliminando los riesgos de contaminación.
La empresa proyecta iniciar la producción en el mercado estadounidense para el primer trimestre de 2026. La dirección señala que un producto anterior en este ámbito fue adquirido por Boston Scientific por 500 millones de dólares, destacando el potencial valor de mercado de esta tecnología.
CS Diagnostics Corp. (OTCQB:CSDX)는 암 방사선 치료를 위한 혁신적인 장기 스페이서 의료 기기인 CS-Protect Hydrogel의 FDA 승인을 지원하기 위해 Lachman Consultants를 임명했습니다. 회사는 3-4개월 이내에 FDA 승인을 받을 것으로 예상하고 있습니다.
CS-Protect Hydrogel은 이전 제품에 비해 향상된 다재다능성을 제공하는 즉시 사용 가능한 제품으로, 고급 분자 구조와 화학적 물리적 특성을 갖추고 있습니다. 이 제품은 멸균 포장에서 제거한 후 준비 단계가 필요 없어 오염 위험을 제거합니다.
회사는 2026년 1분기까지 미국 시장에서 생산을 시작할 계획입니다. 경영진은 이 분야의 이전 제품이 5억 달러에 Boston Scientific에 인수되었음을 언급하며, 이러한 기술의 잠재적 시장 가치를 강조합니다.
CS Diagnostics Corp. (OTCQB:CSDX) a nommé Lachman Consultants pour soutenir l'approbation de la FDA pour son CS-Protect Hydrogel, un dispositif médical innovant de séparation d'organes pour les traitements de radiologie contre le cancer. La société s'attend à obtenir l'approbation de la FDA dans un délai de 3 à 4 mois.
CS-Protect Hydrogel est un produit prêt à l'emploi qui offre une polyvalence améliorée par rapport aux produits précédents, avec une structure moléculaire avancée et des propriétés physico-chimiques. Le produit ne nécessite aucune étape de préparation après avoir été retiré de l'emballage stérile, éliminant ainsi les risques de contamination.
La société prévoit de commencer la production sur le marché américain d'ici le premier trimestre 2026. La direction souligne qu'un produit précédent dans ce domaine a été acquis par Boston Scientific pour 500 millions de dollars, soulignant ainsi la valeur marchande potentielle de cette technologie.
CS Diagnostics Corp. (OTCQB:CSDX) hat Lachman Consultants beauftragt, um die FDA-Zulassung für ihr CS-Protect Hydrogel zu unterstützen, ein innovatives Organabstandshalter-Medizinprodukt für die Strahlentherapie bei Krebs. Das Unternehmen erwartet die FDA-Zulassung innerhalb von 3-4 Monaten.
CS-Protect Hydrogel ist ein gebrauchsfertiges Produkt, das im Vergleich zu früheren Produkten eine verbesserte Vielseitigkeit bietet und über eine fortschrittliche molekulare Struktur sowie chemisch-physikalische Eigenschaften verfügt. Das Produkt erfordert nach der Entnahme aus der sterilen Verpackung keine Vorbereitungsmaßnahmen, wodurch das Risiko einer Kontamination ausgeschlossen wird.
Das Unternehmen plant, die Produktion im US-Markt bis zum ersten Quartal 2026 zu starten. Das Management weist darauf hin, dass ein Vorgängerprodukt in diesem Bereich für 500 Millionen Dollar von Boston Scientific erworben wurde, was den potenziellen Marktwert dieser Technologie unterstreicht.
- Ready-to-use product design eliminates contamination risks
- Enhanced versatility compared to previous products
- Similar predecessor product sold for $500M to Boston Scientific
- Expected short FDA approval timeline of 3-4 months
- Production won't start until Q1 2026, indicating significant time to market
- FDA approval still pending and subject to regulatory risks
CS DIAGNOSTICS CORP. ANNOUNCES THE APPOINTMENT OF FDA CONSULTANTS
Innovative tissue spacer technology for cancer radiology treatments
CHEYENNE, WYOMING / ACCESS Newswire / March 12, 2025 / CS Diagnostics Corp. (OTCQB:CSDX) (or "the company") is delighted to announce the appointment of Lachman Consultants Inc., Westbury, NY www.lachmanconsultants.com to provide its regulatory expertise and support in the company's effort to acquire FDA approval for its CS-Protect Hydrogel.
CS-Protect Hydrogel is an organ spacer medical device that requires registration or approval from the respective governmental authorities, in particular the Food and Drug Administration (FDA) in the USA. Unlike the previous products, CS-Protect Hydrogelis more versatile and can also be used in other pathologies. CS-Protect Hydrogelis an advanced technology from molecular structure, chemical physical properties and medical applications. Registration was preceded by a testing procedure. CS Diagnostics Corp. anticipates a period of 3 to 4 months for approval in the U.S. Market.
Since 1978, Lachman Consultants have furnished expert compliance, regulatory affairs and technical services to clients around the world helping avoid and resolve compliance problems, assisting in the development of efficient and effective strategies for the submission, and approval of drugs and devices. Lachman Consultants serves all areas of global regulatory compliance-related activities for the Pharmaceutical, Biotechnology, Biologics, CGT, Device and Allied Health Industries.
Thomas Fahrhoefer, President of the Board at CS Diagnostics Corp., added:
" The Easy application of the CS-Protect Hydrogel being a ready-to-use product after removal from sterile packaging and unrequired further work steps eliminates any risk of contamination due to preparation and assembly of the product exclusion of another hygienic risk area within the treatment room. Also, no risk of wrong mixture especially wrong sequence and therefore no potential patient's missed treatments. "
Mohammad EsSayed, Vice President of the Board at CS Diagnostics Corp., commented:
" The predecessor product was acquired by Boston Scientific for
Looking toward the future, CS Diagnostics Corp. is positioning itself for long-term growth with breakthrough innovations. As a listed entity on OTCQB, CS Diagnostics Corp. provides U.S. investors with access to a high-growth opportunity, ensuring long-term shareholder value by creating and executing impactful, market-leading solutions.
Forward-Looking Statements
This announcement contains forward-looking statements relating to expected or anticipated future events and anticipated results that are forward-looking in nature and, as a result, are subject to certain risks and uncertainties, such as general economic, market and business conditions, competition for qualified staff, the regulatory process and actions, technical issues, new legislation, uncertainties resulting from potential delays or changes in plans, uncertainties resulting from working in a new political jurisdiction, uncertainties regarding the results of exploration, uncertainties regarding the timing and granting of prospecting rights, uncertainties regarding the timing and granting of regulatory and other third party consents and approvals, uncertainties regarding the Company's or any third party's ability to execute and implement future plans, and the occurrence of unexpected events.
Actual results achieved may vary from the information provided herein because of numerous known and unknown risks, uncertainties, and other factors.
For further information please visit https://csdcorp.us/cs-protect-hydrogel/
or contact
Mohammad Essayed
Email: mohammad.essayed@csdcorp.us
SOURCE: CS Diagnostics Corp.
View the original press release on ACCESS Newswire
FAQ
When is CS Diagnostics (CSDX) expecting FDA approval for CS-Protect Hydrogel?
What are the key advantages of CSDX's CS-Protect Hydrogel over previous products?
When will CSDX begin production of CS-Protect Hydrogel in the US market?
What was the acquisition value of the predecessor product to CSDX's CS-Protect Hydrogel?
